Investigation of the efficacy of a topical dosage form consisting calendula officinalis L., Matricaria recutita L. and Salvia officinalis L extracts in reducing Fluoropyrimidines induced Hand-Foot Syndrome in cancerous patients
The purpose of this study is to introduce a suitable topical product of combination from calendula officinalis, matricaria chamomilla and salvia officinalis to improve Hand-foot syndrome symptoms in cancer patients who are taking Fluoropyrimidine drugs. The study population is cancer patients who are taking IV injection of 5-fluorouracil or oral Capecitabine and showing hand-foot syndrome. These patients are entered in study with consent. Patients in the event of the death or absence of these conditions, as well as allergy to formulation are excluded. The clinical trial of this formulation will be conducted on 20 cancer patients with Hands and foot syndrome of three medical centers in Tehran and Qom, in a double-blind, placebo-controlled and parallel study. Trial group is combination of phase 1 and 2. The sample is consisted of 40 pairs of hands and feet. Patients are randomly divided into two groups, white and orange; white group receive the placebo gel to their hands and the drug gel to their feet; the orange contrary receive the placebo gel to their feet and the drug gel to their hands for two weeks. The beginning and the fourteenth day of study, the severity of lesions are checked, photographed and questionnaire is completed; syndrome is graded according to data by the National Cancer Institute protocols and changes are investigated.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015042116518N2
Registration date:2015-08-04, 1394/05/13
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-08-04, 1394/05/13
Registrant information
Name
Minoo Afshar
Name of organization / entity
Department of Pharmaceutics, Pharmaceutical Sciences Branch, Islamic Azad University
Country
Iran (Islamic Republic of)
Phone
+98 21 2264 0052
Email address
afsharme@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Pharmaceutical Sciences branch, Islamic Azad University
Expected recruitment start date
2015-05-22, 1394/03/01
Expected recruitment end date
2015-08-01, 1394/05/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation of the efficacy of a topical dosage form consisting calendula officinalis L., Matricaria recutita L. and Salvia officinalis L extracts in reducing Fluoropyrimidines induced Hand-Foot Syndrome in cancerous patients
Public title
Investigation of the efficacy of a herbal topical gel in reducing the skin reactions in cancer patients taking chemotherapy drugs
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Taking 5-fluorouracil (5-fu) by injection or oraly Capecitabine as an anticancer drug; showing hand-foot syndrome; patient satisfaction; Having cancer.
Exclusion criteria: Treatment change and discontinuing 5-fluorouracil (5-fu) and oral Capecitabine administration; Showing no hand-foot syndrome; Patient's death; Lack of cancer; Sensitivity to compounds of formula.
Age
No age limit
Gender
Both
Phase
1-2
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Pharmaceutical Sciences branch, Islamic Azad University
Street address
Pharmaceutical Sciences branch, No. 99, Jasmine alley, Yakchal St., Dr. Shariati St.
City
Tehran
Postal code
193956466
Approval date
2013-10-27, 1392/08/05
Ethics committee reference number
9799
Health conditions studied
1
Description of health condition studied
Hand and Foot Syndrome
ICD-10 code
L27.1
ICD-10 code description
Localized skin eruption due to drugs and medicaments
Primary outcomes
1
Description
severity of HFS symptoms
Timepoint
Beginning of the study , the fourteenth day
Method of measurement
NCI Hand-Foot Syndrome staging version 4.0
Secondary outcomes
1
Description
Skin Sensitivity
Timepoint
From the beginning of the study
Method of measurement
Observational
Intervention groups
1
Description
The topical gel will be administrated to the foot or hand of the patients randomly four times a day for two weeks
Category
Treatment - Drugs
2
Description
The topical placebo will be administrated to the foot or hand of the patients taking the topical drug randomly four times a day for two weeks
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Beheshti Hospital
Full name of responsible person
Dr.Behrooz Gharib
Street address
Shahid Beheshti Hospital, Shahid Beheshti st.
City
Qom
2
Recruitment center
Name of recruitment center
Naft Hospital
Full name of responsible person
Dr.Behrooz Gharib
Street address
Naft Hospital, Sarhang Sakhaee st., Hafez st.
City
Tehran
3
Recruitment center
Name of recruitment center
Modarres Hospital
Full name of responsible person
Dr.nematollah rostami
Street address
Modarres Hospital, intersection of Yadegar emam and Saadat abad st.
City
tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Pharmaceutical Sciences branch, Islamic Azad University(a part of Elnaz Karimi's PharmD thesis)
Full name of responsible person
Dr.Sepide Arbabi
Street address
Pharmaceutical Sciences branch, No. 99, Jasmine alley, Yakchal St., Dr. Shariati St.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Pharmaceutical Sciences branch, Islamic Azad University(a part of Elnaz Karimi's PharmD thesis)
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Pharmaceutical Sciences branch, Islamic Azad University
Full name of responsible person
Elnaz Karimi
Position
Basic pharmaceutical PhD student
Other areas of specialty/work
Street address
Pharmaceutical Sciences branch, No. 99, Jasmine alley, Yakchal St., Dr. Shariati St.
City
Tehran
Postal code
Phone
+98 21 4414 2653
Fax
Email
e.karimi90@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Pharmaceutical Sciences branch, Islamic Azad University
Full name of responsible person
Dr.Minoo Afshar
Position
PhD Industrial Pharmacy / faculty
Other areas of specialty/work
Street address
Pharmaceutical Sciences branch, No. 99, Jasmine alley, Yakchal St., Dr. Shariati St.
City
Tehran
Postal code
Phone
+98 21 2264 0051
Fax
Email
afsharme@tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Pharmaceutical Sciences branch, Islamic Azad University
Full name of responsible person
Elnaz Karimi
Position
Basic pharmaceutical PhD student
Other areas of specialty/work
Street address
Pharmaceutical Sciences branch, No. 99, Jasmine alley, Yakchal St., Dr. Shariati St.
City
Tehran
Postal code
Phone
+98 21 4414 2653
Fax
Email
e.karimi90@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)